The Canadian HIV Quit Smoking Trial: Tackling the Co-morbidities of Depression and Cardiovascular Disease in HIV+ Smokers (CANQUIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Ottawa Hospital Research Institute
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
CIHR Canadian HIV Trials Network
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01800019
First received: February 25, 2013
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

The objectives of this trial are:

Primary objectives:

  1. To determine among HIV+ individuals whether varenicline or NRT is more effective at helping individuals remain abstinent from smoking tobacco.
  2. To determine among HIV+ individuals whether varenicline or NRT has the lowest side-effect profile.
  3. To determine if the HIV tailored Quit Smoking Counselling Intervention, plus smoking cessation drug therapy, improves smoking cessation rates compared to smoking cessation drug therapy alone with usual care.

Secondary objective:

1. To determine whether the use of varenicline/NRT is safe in HIV+ patients who exhibit depressive symptoms.

Hypothesis:

That varenicline will result in higher quit smoking rates and that NRT will result in a lower side effect profile. Further, the HIV tailored quit smoking intervention will result in higher rates of smoking cessation over and above the pharmacological treatment alone. And finally, varenicline will be safe to use for HIV + individuals who exhibit depressive symptoms.


Condition Intervention Phase
HIV
Smoking Cessation
Drug: Nicotine Replacement Therapy (NRT)
Drug: Varenicline
Behavioral: HIV Tailored Quit Smoking Counseling
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Canadian HIV Quit Smoking Trial: Tackling the Co-morbidities of Depression and Cardiovascular Disease in HIV+ Smokers

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Smoking Status [ Time Frame: at week 48 ] [ Designated as safety issue: No ]
    The primary study end-point will be seven-day self-reported abstinence, and four week continuous abstinence rates at week 48, confirmed by expired carbon monoxide levels measured using a piCO+ Smokerlyzer (Smoke free defined as exhaled CO < 10 ppm). Study participants who are lost to follow-up (e.g., study drop-outs and those unavailable for follow-up) will be considered as smokers for the purposes of outcome analyses.


Secondary Outcome Measures:
  • Smoking Status: self report [ Time Frame: quit date, weeks 4,8,12,16,20,24 and 48 ] [ Designated as safety issue: No ]

    Seven-day point-prevalence, and 4-week continuous abstinence(if time interval permits), assessed by self-report and by expired carbon monoxide levels measured using a piCO+ Smokerlyzer.

    In addition, self-reported 4-week continuous abstinence rates (CAR) will be reported.


  • Smoking status: CO expired [ Time Frame: randomization, quit date, 4, 8, 12, 16, 20, 24 ] [ Designated as safety issue: No ]
    Smoke free status will be objectively measured by exhaled CO levels (<10ppm) with a Bedfont Smokerlyzer instrument.

  • Smoking cessation treatment integrity and patient satisfaction [ Time Frame: Baseline through Week 48 ] [ Designated as safety issue: Yes ]

    Study Medication: Adherence to NRT and varenicline will be assessed by participant self-reported adherence to medication at each study visit.

    Counseling Intervention: Each clinic site will have an HIV clinic health care provider who will be trained in administering the standardized HIV quit smoking intervention.

    Program Satisfaction Form will be completed by all study participants at the end of the study. At post-quit dates, treatment adherence will be assessed by a self-report measure of the amount of NRT or varenicline taken, number of cigarettes smoked in the previous 7 days, and marked changes in mood.

    Study coordinator will assess rates of discontinuation of varenicline or NRT. Participants who discontinue varenicline or NRT will still be followed according to the original schedule.


  • Behavioral-Psychosocial [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: Yes ]
    • The Minnesota Nicotine Withdrawal Scale
    • The Center for Epidemiological Studies Depression Scale
    • Smoking Self-Efficacy Questionnaire
    • EuroQol(EQ-5D)This scale is a brief, standardized, generic measure of HR-QOL that provides a 5-item profile of patient function and a global health state rating
    • Beck Depression Inventory
    • Experiences in Close Relationships
    • Stages of Change Questionnaire
    • Adherence to Treatment Questionnaire
    • Life Events Questionnaire
    • Use of Cessation Resources Survey

  • Cardiovascular Parameters [ Time Frame: From baseline through 48 weeks ] [ Designated as safety issue: No ]

    The following parameters will be compared:

    1. Weight
    2. Height
    3. Waist circumference (defined by Heart and Stroke Foundation)
    4. Blood pressure

  • Immune Function [ Time Frame: 12, 24, and 48 weeks ] [ Designated as safety issue: No ]

    Changes in:

    1. CD4-T-lymphocyte count and percentage
    2. HIV viral load
    3. CD8-T-lymphocyte count and percentage


Estimated Enrollment: 256
Study Start Date: January 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NRT arm

Drug: Nicotine Replacement Therapy (Nico-Derm® and Nicorette®)

Dose: 7mg - 42mg depending on # of cigarettes smoked per day at study baseline, and withdrawal symptoms.

Mode of Administration: Transdermal Patch

Duration of Treatment: up to 24 Weeks

Additionally, participants will be provided with a supply of short-acting nicotine gum in order to supplement their long acting NRT patch regimen.

Individuals who smoke their first cigarette more than 30 minutes after waking are advised to use the 2 mg NRT gum. Participants who smoke their first cigarette within 30 minutes of waking will be advised to use the 4 mg NRT gum. Both NRT gum dosages will be recommended for use on an ad lib basis to address cravings and/or withdrawal symptoms, up to a maximum of 12 pieces of NRT gum per day.

Drug: Nicotine Replacement Therapy (NRT)
Other Names:
  • Nico-Derm®
  • Nicoderm
  • the patch
  • Nicorette®
  • the gum
Active Comparator: NRT and HIV Tailored Quit Smoking Counseling

Drug: Nicotine Replacement Therapy (Nico-Derm®)

Dose: 7mg - 42mg depending on # of cigarettes smoked per day at study randomization and withdrawal symptoms.

Mode of Administration: Transdermal Patch

Duration of Treatment: up to 24 Weeks

HIV tailored Smoking Cessation Counseling: The counseling consists of face-to-face sessions with a trained smoking cessation counselor at the start of the study, on your chosen quit date, and then at weeks 4, 8, 12 and 24; supportive telephone calls if needed.

Drug: Nicotine Replacement Therapy (NRT)
Other Names:
  • Nico-Derm®
  • Nicoderm
  • the patch
  • Nicorette®
  • the gum
Behavioral: HIV Tailored Quit Smoking Counseling

A cognitive behavioral therapy (CBT) oriented smoking cessation program tailored to HIV positive individuals.

People Living with HIV/AIDS (PHA) tailored Canadian HIV Quit Smoking Counseling Intervention. It consists of face-to-face counseling sessions with a trained smoking cessation counsellor at randomization, on the identified quit date, and then at weeks 4, 8, 12, and 24.

Other Name: Ottawa Model for Smoking Cessation
Active Comparator: Varenicline (VR) Arm

Drug: Varenicline (Champix®)

Doses: 0.5 mg once daily for 3 days(i.e.day 1-3 of the week prior to quit date) 0.5 mg twice daily for 4 days i.e. day 4-7) and 1 mg twice daily for the remainder of the treatment period

Mode of Administration: Oral

Duration of Treatment: 24 Weeks (+ 1 Week of Dose Escalation, total of 25 weeks)

Drug: Varenicline
Other Name: Champix
Active Comparator: Varenicline (VR) and HIV Tailored Quit Smoking Counseling

Drug: Varenicline (Champix®)

0.5 mg once daily for 3 days(i.e.day 1-3 of the week prior to quit date) 0.5 mg twice daily for 4 days i.e. day 4-7) and 1 mg twice daily for the remainder of the treatment period

Mode of Administration: Oral

Duration of Treatment: 24 Weeks (+ 1 Week of Dose Escalation, total of 25 weeks)

Intervention: HIV tailored Smoking Cessation Counseling: The counseling consists of face-to-face sessions with a trained smoking cessation counselor at the start of the study, on your chosen quit date, and then at weeks 4, 8, 12 and 24; supportive telephone calls if needed.

Drug: Varenicline
Other Name: Champix
Behavioral: HIV Tailored Quit Smoking Counseling

A cognitive behavioral therapy (CBT) oriented smoking cessation program tailored to HIV positive individuals.

People Living with HIV/AIDS (PHA) tailored Canadian HIV Quit Smoking Counseling Intervention. It consists of face-to-face counseling sessions with a trained smoking cessation counsellor at randomization, on the identified quit date, and then at weeks 4, 8, 12, and 24.

Other Name: Ottawa Model for Smoking Cessation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV positive
  2. Adult (aged 18 or older)
  3. Current smoker (more than 5 cigarettes per day)
  4. Willing to set a date to quit smoking within the next 2-4 weeks
  5. Currently on ART with an undetectable HIV viral load
  6. Able to read/speak English or French
  7. Able to provide written, informed consent as approved by the Ottawa Health Science Network Research Ethics Board and REBs at participating HIV clinic sites

Exclusion Criteria:

  1. Contraindications to nicotine replacement therapy such as allergy to adhesive, serious cardiac arrhythmias (e.g., tachycardia), or vasospastic disease (e.g., Buerger's disease, Prinzmetal's variant angina)
  2. Contraindications to varenicline such as hypersensitivity to varenicline or to any ingredient in the formulation or component of the container.
  3. Reported previous severe intolerances to nausea or gastrointestinal symptoms.
  4. Pregnant, lactating or planning to become pregnant during the study period or refuses a serum beta-HCG test.
  5. Current severe renal impairment or currently taking Cimetidine
  6. Previous or current seizure disorder and/or is taking anti-epileptic drugs
  7. Psychosis and/or is taking anti-psychotic drugs
  8. Diagnosed with severe major depressive episode requiring hospitalization within the past 12 months, previous psychiatric inpatient admission for any cause within the past 12 months, suicide attempt within the past 12 months active or current suicidal ideations as assessed by the BDI-II.
  9. Current use of bupropion, varenicline or any nicotine replacement therapy.
  10. Use of substances (e.g., crack cocaine) that would interfere with a participant's ability to adhere to the study schedule; determined by site coordinator's discretion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01800019

Contacts
Contact: Louise Balfour, PhD 613-737-8037 lbalfour@toh.on.ca

Locations
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Louise Balfour, PhD         
Principal Investigator: Paul MacPherson, MD         
Principal Investigator: Louise Balfour, Ph.D., C.Psych         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
CIHR Canadian HIV Trials Network
Investigators
Principal Investigator: Louise Balfour, PhD Ottawa Hospital Research Institute
  More Information

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01800019     History of Changes
Other Study ID Numbers: 2011824-01H, CTN 269
Study First Received: February 25, 2013
Last Updated: January 10, 2014
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Additional relevant MeSH terms:
Cardiovascular Diseases
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014